DEVELOPMENT, CONSTRUCTION AND VALIDATION OF A TWO-COMPARTMENT ANALYTICAL INSTRUMENT FOR USE AS AN ALTERNATIVE DISSOLUTION METHOD FOR PHARMACEUTICAL TESTING

The purpose of this research was to develop, construct and validate a two-compartment dissolution testing instrument as an alternative test methodology to the current standard USP apparatus II system. The current USP apparatus II system was developed in the 1970’s and has known defects in its design related to fluid dynamics and bio relevance. This two-compartment dissolution instrument eliminates the issues of fluid dynamic mixing, use of biorelevant media levels and provides clinically relevant data. The two-compartment dissolution instrument was tested in conjunction with GastroPlus simulations to mimic a human model with drug absorbance set to zero. This instrument was able to produce similar gastric and duodenum amount recovery profiles from GastroPlus for the two compounds tested